USPTO Patents Application 10762683

Remarks/Arguments

Applicants have received and carefully reviewed the Final Office Action of the
Examiner mailed May 14, 2007. Currently, claims 1-36 remain pending. Claims 1-36
have been rejected. In this amendment, claims 1, 5, 12, 15, 31, and 33 have been
amended. Favorable consideration of the following remarks is respectfully requested.

Claim Rejections - 35 USC § 102

In paragraph 4 of the Final Office Action, claims 1 , 4-1 1, 22, and 25-36 were
rejected under 35 U.S.C. 102(b) as being anticipated by Vale et al. (U.S. Publication No.
2002/0058963). After careful review, Applicant must respectfully traverse this rejection.

Turning to claim 1, which recites:

1. (Currently Amended) A medical device, comprising:

an elongated tubular member having a proximal segment, a distal
segment, and an inner lumen disposed at least partially therethrough; and

a dilator tip having a proximal section insertable at least in part
within the distal segment;

wherein the proximal section of the dilator tip has an outer
diameter and the distal segment of the elongated tubular member has an
inner diameter smaller than the outer diameter of the proximal section of
the dilator tip;

wherein the proximal section of the dilator tip is positioned at least
in part within the distal segment of the elongated tubular member such that
the distal segment expands around at least a portion of the proximal
section of the dilator tip.

"A claim is anticipated only if each and every element as set forth in the claim is
found, either expressly or inherently described, in a single prior art reference." Verdegaal
Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir.
1987). "The identical invention must be shown in as complete detail as is contained in
the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913,
1920 (Fed. Cir. 1989). (See MPEP § 2131).

Nowhere does Vale et al. appear to teach or suggest, "wherein the proximal
section of the dilator tip has an outer diameter and the distal segment of the elongated
tubular member has an inner diameter smaller than the outer diameter of the proximal
section of the dilator tip" or "wherein the proximal section of the dilator tip is positioned
at least in part within the distal segment of the elongated tubular member such that the

10

distal segment expands around at least a portion of the proximal section of the dilator
tip", as recited in claim 1.

Instead, Vale et al. appears to teach a retrieval catheter 70 having a tapered distal
tip 71. A centering catheter tube 20 is inserted within the retrieval catheter 70. However,
the proximal section of the centering catheter tube 20 appears to have an outer diameter
less than the inner diameter of the retrieval catheter. Also, nowhere does the retrieval
catheter 70 appear to expand around at least a portion of the proximal section of the
centering catheter tube 20. To further illustrate this, Vale et al. recites:

{0085] Referring now to FIGS. 10 to 12 in another embodiment of the
invention, the distal end of the centering catheter tube 20 is in the shape of
an arrowhead 50. The largest outer diameter d i of the distal end 50 of the
centering catheter 1 1 is equal to the outer diameter d? of the retrieva l
catheter tip 19 at the open mouth 40 . This ensures that there is a smooth,
step free crossing profile between the centering catheter distal end 50 and
the retrieval catheter tip 19 in the advancement mode of FIG. 11. Also the
distal end 50 of the centering catheter tube 20 sealingly engages the
retrieval catheter tip 19 in the advancement mode. This enables a centering
catheter tube 20 with a diameter d ^ which is smaller than d i to be used,
thus providing more lumen s pace between the centering catheter tube 20
and the retrieval catheter 10 to facilitate flushing and/or aspiration.

[0090] Referring now to FIG. 18 in another embodiment of the invention
the diameter of the retrieval catheter 10 varies along its longitudinal
length. In this case the diameter dt of the tip 19 of the re trieval catheter 10
is greater than the diameter <L of the remaining length of the retrieval
catheter tube 15. The diameter d> of the tip 19 of the retrieval catheter 10 is
equal to or greater than the diameter d ? of the guide catheter 42. This
allows a retrieval catheter tube 15 of smaller diame ter to be used, thus
providing more lumen space between the retrieval catheter tube 15 and the
guide catheter 42. This extra lumen space enables the injec tion of contrast
media and the like through the guide catheter 42.

[0091] Referring to FIG. 19 there is illustrated another retrieval device 41
according to the invention, which is similar to the retrieval device 1 and
like parts are assigned the same reference numerals. In this case the
retrieval catheter 41 comprises a guide catheter 60 and a centering catheter
1 1, and a separate retrieval catheter is not required. The guide catheter 60
is of sufficiently small diameter to allow it to be advan ced to the site of the
stenosis 30, and the distal end 50 of the centering catheter 1 1 in the shape
of an arrowhead is sized to match the outer diameter of the gui de catheter
60. The largest outer diameter d s of the distal end 50 is equal to the outer
diameter cL of the guide catheter 60. This ensures a smooth, step-free

11

transition between the centering catheter 1 1 and the guide catheter 60.

[0093] The centering catheter 1 1 also provides support to the retrieval
catheter assembly, greatly enhancing the integrity and kink resistance of
the system, so that an ultra low profile, thin wall retrieval catheter 10 can
be used without compromising the integrity of the system. This provides a
very large lumen within the tip 19 of the retrieval catheter 10 to facilitate
the retrieval of large filters with large volumes of captured embolic
material. In one embodiment of the invention the centering catheter has an
inner diameter of 0.76 mm and an outer diameter of 1.63 mm. and the
retrieval catheter has an inner diameter of 1.78 mm and an outer diameter
of 2.08 mm. These dimensions are given as examples only and are by no
means essential to the invention. It will be appreciate that other diameters
may also be used to obtain a retrieval system with structural integrity and
a large retrieval lumen.

Therefore, as can be clearly seen, Vale et al. does not teach each and every element of
claim 1 in as complete of detail. Thus, claim 1 is believed to be not anticipated by Vale
et al. and Applicant respectfully requests withdrawal of the rejection.

Additionally, for similar reasons, as well as others, claims 4-11, which depend
from claim 1 and include significant additional limitations, are believed to be not
anticipated by Vale et al. and Applicant respectfully requests withdrawal of the rejection.

Turning to claim 22, which recites:

22. (Previously Presented) A medical device, comprising:

an elongated tubular member having a proximal segment, a distal
segment, and an inner lumen disposed at least partially therethrough, the
distal segment having an inner diameter; and

a dilator tip insertable at least in part within the distal segment, the
dilator tip having a proximal section having an outer diameter greater than
the inner diameter of the distal segment of the elongated tubular member
forming an interference fit therebetween, a distal section, and an inner
lumen disposed therethrough;

wherein the interference fit between the dilator tip and the distal
segment of the elongated tubular member causes the distal segment of the
elongated tubular member to be radially expanded.

Nowhere does Vale et al. appear to teach or suggest, "a dilator tip insertable at least in
part within the distal segment, the dilator tip having a proximal sec tion having an outer
diameter greater than the inner diameter of the distal segment of th e elongated tubular
member forming an interference fit therebetween, a distal section, and an inner lumen
disposed therethrough" or "wherein the interference fit between the dilator tip and the

12

distal segment of the elongated tubular member causes the distal segment of the
elongated tubular member to he radially expanded ", as recited in claims 22. Therefore,
for similar reasons discussed above, as well as others, claim 22 is believed to be not
anticipated by Vale et al. and Applicant respectfully requests withdrawal of the rejection.

Additionally, for similar reasons, as well as others, claims 25-30, which depend
from claim 22 and include significant additional limitations, are believed to be not
anticipated by Vale et al. and Applicant respectfully requests withdrawal of the rejection.

Turning to claim 31, which recites:

31. (Currently Amended) A system for retrieving an
intravascular device disposed within a body lumen, comprising:

an embolic protection filter disposed about an elongated wire;

a retrieval device configured to radially expand and encompass the
intravascular filter therein, said retrieval device comprising an elongated
tubular member having a proximal segment, a distal segment, and an inner
lumen adapted to slidably receive the elongated wire; and

a dilator tip having a proximal section insertable at least in part
within the distal segment urging the distal segment of the elongated
tubular member to radially expand, said dilator tip configured to engage a
stop disposed about the elongated wire.

Nowhere does Vale et al. appear to teach or suggest, "a dilator tip having a proximal
section insertable at least in part within the distal segment urging the distal segment of
the elongated tubular member to radially expand, said dilator tip configured to engage a
stop disposed about the elongated wire", as recited in claim 31. Therefore, for similar
reasons discussed above, as well as others, claim 3 1 is believed to be not anticipated by
Vale et al. and Applicant respectfully requests withdrawal of the rejection.
Turning to claim 32, which recites:

32. (Previously Presented) A system for retrieving an
intravascular device disposed within a body lumen, comprising:

an embolic protection filter disposed about an elongated wire;

a retrieval device configured to radially expand and encompass the
intravascular filter therein, said retrieval device comprising an elongated
tubular member having a proximal segment, a distal segment, and an inner
lumen adapted to slidably receive the elongated wire; and

a dilator tip insertable at least in part within the distal segment, the
dilator tip including a proximal section configured to tightly fit within the
distal segment, a distal section configured to engage a stop disposed about
the elongated wire, and an inner lumen disposed therethrough configured
to slidably receive the elongated wire;

13

wherein the proximal section of the dilator tip has an outer
diameter and the distal segment of the elongated tubular member has an
inner diameter smaller than the outer diameter of the dilator tip;

wherein the dilator tip is positioned at least in part within the distal
segment of the elongated tubular member such that the distal segment
expands around the proximal section of the dilator tip.

Nowhere does Vale et al. appear to teach or suggest, "a dilator tip insertable at least in

part within the distal segment, the dilator tip including a proximal section configured to

tightly fit within the distal segment , a distal section configured to engage a stop disposed

about the elongated wire, and an inner lumen disposed therethrough configured to

slidably receive the elongated wire", "wherein the proximal section of the dilator tip has

an outer diameter and the distal segment of the elongated tubul ar member has an inner

diameter smaller than the outer diameter of the dilator tin ", or "wherein the dilator tip is

positioned at least in part within the distal segment of the elongated tubular member such

that the distal segment expands around the proximal section of the dilator tip", as recited

in claim 32. Therefore, for similar reasons discussed above, as well as others, claim 32 is

believed to be not anticipated by Vale et al. and Applicant respectfully requests

withdrawal of the rejection.

Turning to claim 33, which recites:

33. (Currently Amended) A medical device, comprising:
an elongated tubular member having a proximal segment, a distal
segment, and an inner lumen disposed at least partially therethrough, the
distal segment formed of an elastic material such that the distal segment is
radially expandable between an unexpanded state and a radially expanded
state; and

a dilator tip including a proximal section, the dilator tip inserted at
least in part within the distal segment, wherein the proximal section of the
dilator tip urges the distal segment of the elongated tubular member into
the radially expanded state.

Nowhere does Vale et al. appear to teach or suggest, "a dilator tip including a proximal
section, the dilator tip inserted at least in part within the distal segment, wherein the
proximal section of the dilator tip urges the distal segment of the elong ated tubular
member into the radially expanded state ", as recited in claim 33. Therefore, for similar
reasons discussed above, as well as others, claim 33 is believed to be not anticipated by
Vale et al. and Applicant respectfully requests withdrawal of the rejection.

14

Additionally, for similar reasons, as well as others, claims 34-36, which depend
from claim 33 and include significant additional limitations, are believed to be not
anticipated by Vale et al. and Applicant respectfully requests withdrawal of the rejection.

Claim Rejections - 35 USC § 103

In paragraph 18 of the Final Office Action, claims 2 and 23 were rejected under
35 U.S.C. 103(a) as being unpatentable over Vale et al. (U.S. Publication No.
2002/0058963) in view of Nilsson (U.S. Patent No. 5,873,851). After careful review,
Applicant must respectfully traverse this rejection.

For similar reasons given above, as well as others, claims 2 and 23, which depend
from claims 1 and 22 and include significant additional limitations, are believed to be
patentable over Vale et al. and Nilsson and Applicant respectfully requests withdrawal of
the rejection.

In paragraph 19 of the Final Office Action, claims 3 and 24 were rejected under
35 U.S.C. 103(a) as being unpatentable over Vale et al. (U.S. Publication No.
2002/0058963) in view of Salahieh et al. (U.S. Publication No. 2004/0127936). After
careful review, Applicant must respectfully traverse this rejection.

For similar reasons given above, as well as others, claims 3 and 24, which depend
from claims 1 and 22 and include significant additional limitations, are believed to be
patentable over Vale et al. and Salahieh et al. and Applicant respectfully requests
withdrawal of the rejection.

In paragraph 20 of the Final Office Action, claims 12 and 14-21 were rejected
under 35 U.S.C. 103(a) as being unpatentable over Vale et al. (U.S. Publication No.
2002/0058963) in view of Salahieh et al. (U.S. Publication No. 2004/0058963). After
careful review, Applicant must respectfully traverse this rejection.

Turning to claim 12, which recites:

12. (Currently Amended) A medical device, comprising:
an elongated tubular member having a proximal segment, a distal
segment, and an inner lumen disposed at least partially therethrough, the
distal segment including at least a portion including a braid, the distal
segment configured to radially expand between an unexpanded state and a
radially expanded state; and

15

a dilator tip having a proximal section inserted at least in part
within the portion of the distal segment including the braid, wherein the
proximal section of the dilator tip urges the distal segment of the elongated
tubular member into the radially expanded state.

To establish prima facie obviousness of a claimed invention, all the claim
limitations must be taught or suggested by the prior art. In re Royka, 490 F.2d 981, 180
USPQ 580 (CCPA 1974). (See MPEP § 2143.01). As discussed previously, nowhere
does Vale et al. appear to teach or suggest, "a dilator tip having a proximal section
inserted at least in part within the portion of the distal segment including the braid,
wherein the proximal section of the dilator tip urges the distal s egment of the elongated
tubular member into the radially expanded state ", as recited in claim 12. Furthermore,
nowhere does Salahieh et al. appear to remedy the shortcomings of Vale et al. Therefore,
for similar reasons discussed above, as well as others, claim 12 is believed to be
patentable over Vale et al. in view of Salahieh et al. and Applicant respectfully requests
withdrawal of the rejection.

Additionally, for similar reasons given above, as well as others, claims 14-21,
which depend from claim 12 and include significant additional limitations, are believed
to be patentable over Vale et al. and Salahieh et al. and Applicant respectfully requests
withdrawal of the rejection.

In paragraph 28 of the Final Office Action, claim 13 was rejected under 35 U.S.C.
103(a) as being unpatentable over Vale et al. (U.S. Publication No. 2002/0058963) in
view of Salahieh et al. (U.S. Publication No. 2004/0127936) and further in view of
Nilsson (U.S. Patent No. 5,873,85 1). After careful review, Applicant must respectfully
traverse this rejection.

For similar reasons given above, as well as others, claim 13, which depends from
claims 12 and includes significant additional limitations, is believed to be patentable over
Vale et al. and Salahieh et al. and further in view of Nilsson and Applicant respectfully
requests withdrawal of the rejection.

In view of the foregoing, all pending claims, namely claims 1-36, are believed to
be in a condition for allowance. Reexamination and reconsideration are respectfully
requested. Issuance of a Notice of Allowance in due course is anticipated. If a telephone

16

conference might be of assistance.
9050.

please contact the undersigned attorney at (612) 677-

Respectfully submitted,
THOMAS E. BROOME ET AL.
/By? th/if Attorney,/

Glenn M. Scagerjfe^g. No. 36,926
CROMPTON, SE&GER & TUFTE, LLC
1221 Nicollet Avenue, Suite 800
Minneapolis, Minnesota 55403-2420
Tel: (612) 677-9050

17